Method and system for providing automated high scale fabrication of custom items

ABSTRACT

Method and system for providing volume manufacturing of customizable items including receiving a data package including a plurality of manufacturing parameters, each of the plurality of manufacturing parameters associated with a unique item, verifying the received data package, and implementing a manufacturing process associated with the received data package is provided.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a divisional application of co-pending applicationSer. No. 16/371,479, filed on Apr. 1, 2019, issuing May 11, 2021 as U.S.Pat. No. 11,004,159; which is a divisional application Ser. No.15/611,593, filed on Jun. 1, 2017, now U.S. Pat. No. 10,255,407; whichis a continuation application of application Ser. No. 13/085,079 filedon Apr. 12, 2011, now U.S. Pat. No. 9,691,110; which is a divisionalapplication of application Ser. No. 11/681,615 filed on Mar. 2, 2007,now U.S. Pat. No. 7,957,824. The disclosures of all the aforementionedapplications are incorporated herein by reference in their entireties.

FIELD OF THE INVENTION

The present invention is related generally to the field ofmanufacturing. More specifically, the present invention is related tomethods and system for providing high scale automated manufacturing ofunique items including dental aligners.

BACKGROUND

Traditional methods of dental mold making are well known, such as thosedescribed in Graber, Orthodontics: Principle and Practice, SecondEdition, Saunders, Philadelphia, 1969, pp. 401 415. Typically, thesemethods involve forming an impression of the patient's dentition using asuitable impression material, such as alginate or polyvinylsiloxane(PVS). Impressions of the upper jaw typically include the teeth, thepalate and gingival tissue surrounding the teeth on the facial andlingual surfaces. Impressions of the lower jaw typically include theteeth and gingival tissue surrounding the teeth on the facial andlingual surfaces. Plaster is then poured into the impression to form arelief of the dental features. The relief is a permanent,three-dimensional mold of the dentition and oral tissues.

Improved methods of mold making include rapid prototyping. Rapidprototyping is a technology which has developed in the last decade.Through the use of modern solid modeling CAD packages, combined withlaser systems and new materials, solid parts may now be generateddirectly from a computer model. Examples of this technology includestereolithography (SLA), laminate object manufacturing (LOM), and fuseddeposition modeling (FDM), to name a few.

Stereolithography is a method that employs an ultraviolet laser to curea thin layer of liquid plastic into a solid. The process operates bytaking a thin layer of the light-sensitive liquid plastic and passingthe laser beam over the points where the part is solid. Once a pass iscompleted, another layer of the liquid is added to the existing part,and the process repeats until the full part height is achieved. SLAparts are extremely accurate, and tend to have excellent surfacefinishes. A variety of SLA materials are available for differentpurposes, including waxes, plastics, and flexible elastomers.

Laminate object manufacturing builds a part by taking individual sheetsof paper that have a layer of glue on one side and building upsuccessive sections of a part. As each layer is laid down, a laser beampasses over the edges of the part, detailing the part and separating thepart from the excess material. In addition, the laser beam creates agrid throughout the excess material. After the final sheet is laid down,the part may be separated from the excess material by removing cubes ofthe grid in a systematic fashion. LOM parts are accurate, and very easyto sand and paint. LOM parts also have different strengths in differentdirections due to the paper layers.

Fused deposition modeling is a process that most closely resembles aminiature glue gun. In fused deposition modeling, a heat softening andcuring plastic is melted in a small nozzle which puts down a very finebead wherever the solid part is supposed to be. FDM parts have a roughersurface finish than an SLA part, but typically are stronger and moredurable. In all cases, parts created by rapid prototyping methods aregenerated relatively quickly and are accurate to a few thousandths of aninch.

Producing a dental mold with rapid prototyping methods requires the useof a computerized model or digital data set representing the dentalgeometry and tooth configuration. The model is used to guide the moldmaking process to produce a replica or relief of the computerized model.The resulting relief is a three-dimensional mold of the dentition. Thismethod of making dental molds is particularly applicable to situationsin which multiple molds are needed to be produced. In this case, onecomputerized model may be used to make a number of molds in an automatedfashion. In addition, this method is applicable to situations in which amold of a tooth arrangement which differs from the patient's currenttooth arrangement is needed to be produced or molds of multiple tootharrangements which differ from each other and the patient need to beproduced. In either case, the computerized model of the patient's teethmay be manipulated to portray each new tooth arrangement and a mold maybe produced to reflect each successive arrangement. This may be repeatedany number of times to derive a number of molds with differing tootharrangements. Such techniques may speed production time and reduce costsby eliminating the need for repeated casting and artistic resetting ofteeth in traditional mold manufacturing.

Series of dental molds, such as those described above, may be used inthe generation of elastic repositioning appliances for a new type oforthodontic treatment being developed by Align Technology, Inc., SantaClara, Calif., assignee of the present application. Such appliances aregenerated by thermoforming a thin sheet of elastic material over a moldof a desired tooth arrangement to form a shell. The shell of the desiredtooth arrangement generally conforms to a patient's teeth but isslightly out of alignment with the initial tooth configuration.Placement of the elastic positioner over the teeth applies controlledforces in specific locations to gradually move the teeth into thedesired configuration. Repetition of this process with successiveappliances comprising new configurations eventually moves the teeththrough a series of intermediate configurations to a final desiredconfiguration. A full description of an exemplary elastic polymericpositioning appliance is described in U.S. Pat. No. 5,975,893, and inpublished PCT application WO 98/58596 which designates the United Statesand which is assigned to the assignee of the present invention. Bothdocuments are incorporated by reference for all purposes.

To carry out such orthodontic treatment, a series of computer models ordigital data sets will be generated, stored and utilized to fabricate aseries of representative dental molds. Typically, only the digitalinformation related to the tooth arrangement will be stored due to costand space limitations. However, to form a properly fitting elasticrepositioning appliance or other dental appliance, it will at times benecessary to include in the mold a patient's oral soft tissue, such as apalate, facial gingival tissue and/or lingual gingiva tissue. This maybe the case when adding accessories to a basic elastic repositioningshell, such as palatal bars, lingual flanges, lingual pads, buccalshields, buccinator bows or wire shields, a full description of which isdescribed in U.S. Provisional Patent Application No. 60/199,649 filedApr. 25, 2000, and the full disclosure is hereby incorporated byreference for all purposes. These accessories may contact or interactwith portions of the soft tissue requiring a mold of such tissues toproperly position the accessory in or on the appliance. In addition,this may be the case when producing traditional orthodontic retainersand positioners. Traditional appliances may be used as part of anorthodontic treatment plan utilizing elastic repositioning appliances,particularly in the final stages of treatment. During such stages, forexample, any residual intrusion of the teeth due to the presence ofelastic appliances may be corrected with the use of a traditionalretainer. Such retainers typically comprise a polymeric replica of thepalate or portions of the gingiva which support metal wires which wraparound the perimeter of the teeth.

Existing fabrication systems are generally run manually by generating areport of cases and providing it into the fabrication software. Suchfabrication systems had several disadvantages. First, each mold was notuniquely identifiable. Second, the molds were created with problems ofholes, free-floating island structures, and unstable peninsulastructures. Third, the molds were too tall and used more resin thanrequired. Fourth, the molds were not packed efficiently on a tray.Fifth, laser marks were sometimes not sharp.

Thus, a need exists to promptly process treated three-dimensional (“3D”)jaw and teeth data to create, in an automated manner, 3D mold data formanufacturing. Also created would be a 3D cutting path for automatedcutting of aligners and 3D placement data for automated laser marking ofaligners. These are to be achieved while minimizing resin used to builda mold, minimizing time to build a tray of molds, maximizing automationby reducing manual cutting of aligner, manual laser marking and errors.

In view of the foregoing, it would be desirable to have methods andsystems to provide an automated or semi-automated manufacturing orfabrication process for high volume and high scale customized items suchas dental aligners.

SUMMARY OF THE INVENTION

In view of the foregoing, in accordance with the various embodiments ofthe present invention, there are provided methods and system forproviding high scale and high volume automated fabrication process forcustomized items including, for example, dental aligners, customizedfootwear, customized garment, customized eye wear (including, forexample, contact lenses, and sunglasses), and any other customized orunique items that require unique parameters or specification formanufacturing.

Accordingly, a method of providing volume manufacturing of items in oneembodiment of the present invention includes receiving a data packageincluding a plurality of manufacturing parameters, each of the pluralityof manufacturing parameters associated with a unique item, verifying thereceived data package, and implementing a manufacturing processassociated with the received data package.

These and other features and advantages of the present invention will beunderstood upon consideration of the following detailed description ofthe invention and the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A is a block diagram of the overall fabrication system forpracticing the various embodiments of the present invention;

FIG. 1B is a block diagram of the central manufacturing terminal of theoverall fabrication system of FIG. 1A in accordance with one embodimentof the present invention;

FIG. 2 is a flowchart illustrating the automated fabrication procedureperformed by the central manufacturing terminal of the overallfabrication system of FIG. 1A in accordance with one embodiment of thepresent invention;

FIG. 3 is a flowchart illustrating the fabrication data packageretrieval procedure of FIG. 2 in accordance with one embodiment of thepresent invention;

FIG. 4 is a flowchart illustrating the fabrication data package requestprocedure of FIG. 3 in accordance with one embodiment of the presentinvention;

FIG. 5 is a flowchart illustrating the retrieved fabrication datapackage verification procedure of FIG. 2 in accordance with oneembodiment of the present invention;

FIG. 6 is a flowchart illustrating fabrication data package processingexecution by the central manufacturing terminal of FIG. 1B in accordancewith one embodiment of the present invention;

FIG. 7 is a flowchart illustrating fabrication data package processingexecution by one or more fabrication terminals of FIG. 1B in accordancewith one embodiment of the present invention;

FIG. 8 is a flowchart illustrating the mold object generation procedureof FIG. 7 in accordance with one embodiment of the present invention;

FIG. 9 is a flowchart illustrating the tray object generation procedureof FIG. 7 in accordance with one embodiment of the present invention;

FIG. 10 is a flowchart illustrating the slice format generationprocedure of FIG. 7 in accordance with one embodiment of the presentinvention;

FIG. 11 is a three-dimensional representation of a cutting geometryprofile of FIG. 8 in accordance with one embodiment of the presentinvention;

FIG. 12 is a three-dimensional representation of identificationinformation of FIG. 8 in accordance with one embodiment of the presentinvention; and

FIGS. 13A-13B are visual illustrations of a column oriented andrecursive layouts, respectively, of the optimal tray layout of FIG. 9 inaccordance with one embodiment of the present invention.

DETAILED DESCRIPTION

FIG. 1A is a block diagram of the overall fabrication system forpracticing the various embodiments of the present invention. Referringto FIG. 1A, in one embodiment of the present invention, the fabricationsystem 100 includes a data network 110, a remote terminal 120 and acentral manufacturing terminal 130. The central manufacturing terminal130 and the remote terminal 120 are each operatively coupled to the datanetwork 110 for bi-directional communication. In one embodiment, thedata network 110 includes one or more of a public data network such asthe internet, a private data network including, for example, anintranet, a local area network (LAN), a wide area network (WAN), or anyother data network that provides for secure data communication includingdata encryption and the like.

Referring to FIG. 1A, the fabrication system 100 further includes aplurality of fabrication terminals 140A, 140B, each of which areoperatively coupled to the central manufacturing terminal 130. In oneembodiment, each of the plurality of fabrication terminals 140A, 140Bmay be configured to perform one or more dedicated processing to supportthe fabrication process. Alternatively, the one or more of thefabrication terminals 140A, 140B may be configured to perform duplicatefabrication processing to provide redundancy in case of failure of oneor more fabrication terminals 140A, 140B. While two fabricationterminals 140A, 140B are shown in FIG. 1A, within the scope of thepresent invention, additional fabrication terminals may be provided,each configured to communicate with the central manufacturing terminal130, and further, each additional fabrication terminal configured toperform one or more dedicated or redundant fabrication processing.

Referring yet again to FIG. 1A, the remote terminal 120 may beconfigured as a personal computer, a workstation, or a server terminal,a handheld mobile device or any other suitable device configured tosupport data communication with the data network 110 and related dataprocessing, and further, configured to communicate with the centralmanufacturing terminal 130 in the fabrication system 100. Likewise, inone embodiment, the central manufacturing terminal 130 and each of thefabrication terminals 140A, 140B may be configured as a personalcomputer, a workstation, a server terminal, a handheld mobile device orany other suitable device configured to support data communication andrelated processing in the fabrication system 100.

For example, in one embodiment, as discussed in further detail below,the remote terminal 120 may be configured to support manufacturingexecution system (MES) which monitors a customer order for thecustomized items such as dental appliances, from the initial orderplacement, through manufacturing and shipping to the customer. Inaddition, the remote terminal 120 may also be configured to supportexecutable programs for processing and generating appropriatefabrication related data files and formats. More specifically, in oneembodiment, the remote terminal 120 may be configured to support andexecute ClinCheck® software which, for example, provides for electronicdental treatment plan generation and data files (for example, the ADFfile format corresponding to three-dimensional data format for jaw andteeth representation) associated with the manufacturing of the dentalappliances for the dental treatment.

FIG. 1B is a block diagram of the central manufacturing terminal of theoverall fabrication system of FIG. 1A in accordance with one embodimentof the present invention. Referring to FIG. 1B, the centralmanufacturing terminal 130 in one embodiment includes a storage unit130A, a communication interface 130B and a processing unit 130Coperatively coupled to the storage unit 130A and the communicationinterface 130B.

Referring to FIG. 1B, the storage unit 130A in one embodiment may beconfigured to provide persistent (nonvolatile) storage for program anddata files, and may include at least one hard disk drive and at leastone CD-ROM drive (with associated removable media). There may also beother devices such as a floppy disk drive and optical drives (all withtheir associated removable media). In addition, the storage unit 130Amay include drives of the type with removable media cartridges, such ashard disk cartridges and flexible disk cartridges. In one aspect of thepresent invention, the processing unit 130C may be configured to accesssoftware stored in the storage unit 130A based on and in response to theinput command or request received via the communication interface 130Bto perform corresponding associated processing based on proceduresand/or routines in accordance with the instructions or input informationreceived via the communication interface 130B.

Referring again to FIG. 1B, the communication interface 130B in oneembodiment is operatively coupled to a communication link 130D fortransmitting and/or receiving data including instructions associatedwith the operation of the central manufacturing terminal 130. In oneembodiment, the communication link 130D may include wired or wirelesscommunication link for bi-directional communication with remote terminal120 over the data network 110, and further, with the one or morefabrication terminals 140A, 140B.

Referring back to FIG. 1A, while not shown, in one embodiment of thepresent invention, each of the remote terminal 120, and the one or morefabrication terminal 140A, 140B may be configured with one or moreprocessing units, one or more storage units, and one or morecommunication interface similar to those respective components shown inFIG. 1B in conjunction with the central manufacturing terminal 130, forperforming the dedicated or associated functions in conjunction with therespective data processing and communication in the fabrication system100.

FIG. 2 is a flowchart illustrating the automated fabrication procedureperformed by the central manufacturing terminal of the overallfabrication system of FIG. 1A in accordance with one embodiment of thepresent invention. Referring to FIG. 2, in one embodiment, at step 210,a data processing clock of the central manufacturing terminal 130 (FIG.1B), for example, in the processing unit 130C of the centralmanufacturing terminal 130 is initiated. More specifically, in oneembodiment, a predetermined fabrication processing stop time, oralternatively, a predefined fabrication processing time period (as maybe defined or pre-programmed in the central manufacturing terminal 130)is initiated.

Referring to FIG. 2, at step 220, the fabrication data package isretrieved from, for example, the remote terminal 120 (FIG. 1A) over thedata network 110. That is, at the time of initiating the data processingclock, the data package at the remote terminal 120 is prepared andfinalized for transmission to the central manufacturing terminal 130. Inone embodiment, the data package may include a predefined data formatsuch as ADF files which provides associated three-dimensional datarepresentation of the jaw and teeth for each treatment profile for eachpatient for purposes of manufacturing and processing of the moldsincluding the cutting and laser marking of the aligners. In oneembodiment, the data package is processed by manufacturing executionsystem resident in the remote terminal 120 and which is configured tomonitor customer orders from the initial order placement to the ordershipment to the customer.

Referring again to FIG. 2, upon retrieving the fabrication data package,at step 230, the retrieved fabrication data package is verified at step230 for accuracy to ensure, for example, that the fabrication datapackage includes all data associated with each customer order and theassociated treatment profile for fabrication processing includingaccuracy and completeness of all stages of each treatment profile forfabrication processing. Upon verification of the retrieved fabricationdata package, the fabrication processing is executed at step 240 for theretrieved fabrication data package. Upon verification of the retrievedfabrication data package, the central manufacturing terminal 130 in oneembodiment is configured to generate a notification message confirmingthe verification of the received fabrication data package and totransmit the notification to the remote terminal 120.

During fabrication processing, the central manufacturing terminal 130 inone embodiment may be configured to generate a status report and outputto the remote terminal 120 to update the remote terminal 120 on thefabrication processing status of the retrieved fabrication data package.Periodically, at predetermined intervals, the central manufacturingterminal 130 may be configured to generate input data for use during thelater stages in the manufacturing line. For example, in particularembodiments, the central manufacturing terminal 130 may be configured togenerate identification of the three-dimensional mold objects data,location of the cutting program, and location of the laser marking datafor use during later stages in the manufacturing line.

Referring still again to FIG. 2, at step 250, it is determined whetherthe data processing clock initiated at step 210 has expired. If it isdetermined that the data processing clock associated with thefabrication processing has not elapsed, then the procedure returns tostep 220 to retrieve additional fabrication data package for processingby the central manufacturing terminal 130. More specifically, in oneembodiment, the fabrication process of the central manufacturingterminal 130 is optimized so as to utilize the processing capacity forhandling high volume manufacturing processing so as to optimize theprocessing load of the central manufacturing terminal 130 and the one ormore fabrication terminals 140A, 140B. That is, as discussed in furtherdetail below, in one embodiment, the central manufacturing terminal 130is configured to monitor the status of the fabrication data packageprocessing, and when it is determined that the fabrication data packageprocessing is nearing completion in the processing cycle, the centralmanufacturing terminal 130 may be configured to prompt the remoteterminal 120 to retrieve additional fabrication data packages formanufacturing processing. In this manner, in one embodiment, theoperational status of the one or more fabrication terminals 140A, 140Bare monitored to minimize idle time, and further to optimize thefabrication processing load of the fabrication system 100.

Referring back to FIG. 2, if at step 250 it is determined that the dataprocessing clock has expired or, if it is determined that the predefinedprocessing time period has elapsed, the central manufacturing terminal130 in one embodiment is configured to generate a status report andoutput to the remote terminal 120 to update the remote terminal 120 onthe fabrication processing status of the retrieved fabrication datapackage. In a further embodiment, the central manufacturing terminal 130may be configured to archive or backup all data or information receivedand/or processed by the central manufacturing terminal 130, to generatea final input data for use during later stages in the manufacturingline. For example, in particular embodiments, the archived or backed updata or information may include identification of the three-dimensionalmold objects data, location of the cutting program, or location of thelaser marking data.

In one embodiment of the present invention, the central manufacturingterminal 130 may be configured to periodically generate and transmit astatus report or notification to the remote terminal 120 for each of thefabrication data package retrieved and executed for processing. Morespecifically, in one embodiment, the central manufacturing terminal 130may be configured to generate a status notification at a predeterminedtime interval for each fabrication data package in the manufacturingprocess, or alternatively (or in addition to), the central manufacturingterminal 130 may be configured to generate and transmit a status reportof the fabrication data package in manufacturing process based on thedetection of a predefined error condition associated with thefabrication data package. In this manner, in the case where thepredefined error condition requires modification to the data package,the error condition may be addressed at the remote terminal 120, forexample, and communicated to the central manufacturing terminal 130substantially contemporaneous to the detection of the error condition sothat the manufacturing process is optimized with minimal idle ordowntime.

FIG. 3 is a flowchart illustrating the fabrication data packageretrieval procedure of FIG. 2 in accordance with one embodiment of thepresent invention. Referring to FIG. 3, in one embodiment, a currentactive fabrication process load associated with the retrievedfabrication data package is retrieved at step 310 by the centralmanufacturing terminal 130 from the remote terminal 120. Thereafter atstep 320, it is determined whether the retrieved current activefabrication process load is less than a predetermined active processload of the fabrication system 100 (FIG. 1A). In one embodiment, thepredetermined active process load of the fabrication system 100 may bedefined or established by the central manufacturing terminal 130 basedon, for example, the operational status of the one or more fabricationterminals 140A, 140B in the fabrication system 100.

Referring to FIG. 3, if it is determined that the current activefabrication process load is not less that the predetermined activeprocess load, then the routine is timed out for a predetermined timeperiod at step 340, and then the routine returns to step 310. That is,if it is determined that the fabrication processing is at a predefinedoptimal manufacturing process status based on the retrieved fabricationdata package, the central manufacturing terminal 130 in one embodimentis configured to not request additional fabrication data package for thecurrent or active manufacturing cycle. On the other hand, referringagain to FIG. 3, if it is determined that the current active fabricationprocess load is less than the predetermined active process load of thefabrication system 100 for the current manufacturing cycle, then at step330, additional fabrication data package request is transmitted to theremote terminal 120 (FIG. 1A) to optimize the current manufacturingcycle processing load, and in response thereto, the requested additionalfabrication data package is received at step 350 by the centralmanufacturing terminal 130.

In this manner, in one embodiment of the present invention, the centralmanufacturing terminal 130 is configured to initiate the fabricationprocess based on the received fabrication data package when sufficientfabrication data package is received from the remote terminal 120. Assuch, the manufacturing cycle processing load may be optimized in oneembodiment to initiate the fabrication process when sufficientfabrication data package is received. Indeed, the fabrication system 100in one embodiment may be configured to initiate the manufacturingprocess associated with the fabrication data package to take advantageof the processing volume which the fabrication system 100 is configuredto support.

FIG. 4 is a flowchart illustrating the fabrication data package requeststep 330 of FIG. 3 in accordance with one embodiment of the presentinvention. More specifically, referring to FIG. 4, in one embodiment ofthe present invention, at step 410, the available fabrication datapackage for fabrication processing is determined. Thereafter, at step420, it is determined whether the available fabrication data package isless than the total active fabrication process capacity. If it isdetermined that the available fabrication data package is less than thetotal active fabrication process capacity at step 420, then at step 430,all available fabrication data package is requested for fabricationprocessing. That is, in one embodiment, the central manufacturingterminal 130 (FIG. 1B) may be configured to transmit a request to theremote terminal 120 for all available fabrication data package forfabrication processing by the fabrication system 100.

Referring back to FIG. 4, if at step 420 it is determined that theavailable fabrication data package is not less than the total activefabrication process capacity, then at step 440, the availablefabrication process capacity is determined to estimate, for example, theadditional fabrication data package which may be processed in thecurrent manufacturing cycle, and at step 450, the incrementalfabrication data package corresponding to the determined availablefabrication process capacity is requested for concurrent processing withthe active fabrication cycle.

FIG. 5 is a flowchart illustrating the retrieved fabrication datapackage verification procedure of FIG. 2 in accordance with oneembodiment of the present invention. Referring to FIG. 5, the procedurefor verifying the retrieved fabrication data package in one embodimentincludes analyzing the retrieved fabrication data package at step 510.Thereafter at step 520, it is determined if there are any missing datain the analyzed fabrication data package. More specifically, in oneembodiment, data package associated with each treatment profile isreviewed for any missing treatment profile stage information. Forexample, for a treatment profile including 20 stages, data package foreach of the 20 stages is reviewed to ensure that all associated datarelated to the 20 stages are received for the treatment profile.

If it is determined that there are missing data in the receivedfabrication data package, at step 530, an associated error notificationis generated and transmitted to, for example, the remote terminal 120(FIG. 1A). Thereafter, at step 550, the missing (or corrected) datapackage is requested at step 550. In other words, in one embodiment, inthe event that the central manufacturing terminal 130 determines thatthe fabrication data package received from the remote terminal 120 doesnot include all of the data associated with the identified treatmentprofiles for fabrication processing, the central manufacturing terminal130 is configured to identify the missing data information, and torequest the missing data from the remote terminal 120 prior toinitiating the fabrication processing of the fabrication data package.

Referring back to FIG. 5, if at step 520 it is determined that there areno missing data in the fabrication data package received, then at step540 it is determined whether any of the data in the received fabricationdata package includes one or more errors. That is, in one embodiment,the central manufacturing terminal 130 is configured to check for theintegrity of the data in the received fabrication data package, foraccuracy. If there are not invalid or erroneous data identified in thefabrication data package, then the routine terminates. On the otherhand, if at step 540 it is determined the received fabrication datapackage includes invalid data associated with one or more stages of oneor more identified treatment profiles for fabrication processing, thenas described above, the routine returns to step 530 to generate andtransmit one or more associated error notification, and thereafter, atstep 540, a corrected data package is requested.

In the manner described above, in one embodiment of the presentinvention, the central manufacturing terminal 130 may be configured toverify the integrity of the received or retrieved fabrication datapackage before the fabrication processing cycle is initiated.Accordingly, once the fabrication processing cycle is initiated, in oneaspect, it is possible to minimize potential disruption to thefabrication processing cycle based on erroneous or missing data in thefabrication data package.

FIG. 6 is a flowchart illustrating fabrication data package processingexecution by the central manufacturing terminal of FIG. 1B in accordancewith one embodiment of the present invention. Referring to FIG. 6, inone embodiment, the fabrication data package processing is executed by,for example, parsing the fabrication data package into a predeterminednumber of processing batches at step 620. Thereafter, at step 620, eachof the predetermined number of processing batches of the parsedfabrication data package is transmitted to a corresponding one or morefabrication terminals 140A, 140B (FIG. 1A) for processing and executionbased on the parsed fabrication data package.

For example, in one embodiment of the present invention, each of thefabrication terminals 140A, 140B may be configured to execute one ormore dedicated processes associated with one or more aspects of thefabrication system 100. Accordingly, the central manufacturing terminal130 is configured to substantially concurrently initiate the executionof one or more processes associated with each of the one or more parseddata packages for each fabrication terminal 140A, 140B. In this manner,fabrication processing by the central manufacturing terminal 130 may bedivided into sub-tasks or sub-routines and performed substantially inparallel and concurrently to optimize the fabrication processing cycle.

FIG. 7 is a flowchart illustrating fabrication data package processingexecution by one or more fabrication terminals of FIG. 1A in accordancewith one embodiment of the present invention. More specifically,referring to FIG. 7, at step 710 each of the fabrication terminals 140A,140B in one embodiment receives a data batch from the centralmanufacturing terminal 130, and at step 720, is configured to converteach stage of the received batch data into a correspondingthree-dimensional mold object data. In one aspect, eachthree-dimensional mold object data may correspond to one stage of aplurality stages of a treatment profile of the fabrication data package.Thereafter, a tray object data based on the mold object data isgenerated at step 730, which is then converted to a slice format datafor mold cutting from the tray.

That is, in one embodiment, the one or more fabrication terminals 140A,140B may be configured to receive one or more batch data from thecentral manufacturing terminal 130, and to convert the received batchdata into a three-dimensional mold object data which corresponds to thereceived one or more batch data. Thereafter, the one or more fabricationterminals 140A, 140B may be further configured to generate athree-dimensional tray object data which corresponds to an optimizedlayout information of the plurality of mold data (for example, eachcorresponding to one stage of the plurality of stages of the treatmentprofile) to minimize material wastage and optimize the volume of moldobjects that may be provided on each mold tray prior to cutting. Afterperforming the optimized layout of the tray based on the mold objects,the tray object data is converted into a polygonal format, for example,to allow slicing of each mold from the tray.

In one embodiment of the present invention, each of the fabricationterminal 140A, 140B may be configured to perform one or more of thededicated functions associated with the conversion of each stage of thebatch data into a corresponding three-dimensional object data, thegeneration of the tray object data based on the mold object data, andthe conversion of the tray object data into the slice format in thefabrication processing.

FIG. 8 is a flowchart illustrating the mold object generation procedureof FIG. 7 in accordance with one embodiment of the present invention.More specifically, in one embodiment of the present invention, theconversion of each stage of the batch data into a correspondingthree-dimensional mold object data includes retrieving at step 810 acutting geometry profile and an identification information for a dentalaligner associated with each stage of the dental treatment profile inthe fabrication data package. Thereafter, a corresponding machineexecutable data file is (for example, a GCode file) is generated that isassociated with the cutting geometry and identification information ofeach stage of the treatment profile.

More particularly, in one embodiment, the one or more fabricationterminal 140A, 140B is configured to generate the machine executabledata file which includes the cutting geometry and identificationinformation (for example, the customer identification number, the stageof the treatment profile information, and the like) for each dentalappliance for each stage of the treatment profile. For example, FIG. 11illustrates a three-dimensional representation of a cutting geometryprofile, and FIG. 12 illustrates a three-dimensional representation ofidentification information of a dental appliance in accordance with oneembodiment of the present invention.

FIG. 9 is a flowchart illustrating the tray object generation procedureof FIG. 7 in accordance with one embodiment of the present invention.Referring now to FIG. 9, in one embodiment, the tray object data isgenerated based on the three-dimensional mold object by, for example,retrieving all three-dimensional mold object data in the fabricationdata package in the fabrication processing cycle at step 910, and atstep 910, an optimal tray layout is determined based on the retrievedthree-dimensional mold objects data.

For example, referring to FIGS. 13A-13B, visual illustrations of acolumn oriented and recursive layouts, respectively, of the optimal traylayout are shown in accordance with one embodiment of the presentinvention. Indeed, in one embodiment of the present invention, theoptimal tray layout in one embodiment is determined based on theretrieved three-dimensional mold objects data so as to optimize thespacing and material usage of each dental appliance associated with eachstage of each treatment profile associated with the fabrication datapackage.

Referring back to FIG. 9, upon determination of the optimal tray layout,the tray object file is generated based on the optimized layoutinformation. For example, in FIG. 13A, a three-dimensional columnoriented layout of the mold objects are shown in one embodiment, whilein FIG. 13B, a three-dimensional recursive layout of the mold objectsfor batch processing is shown. In this manner, in one embodiment of thepresent invention, the adjacent columns as shown in FIGS. 13A, 13B areoriented in opposite direction to optimize the tray layout. In oneaspect, the tray layout optimization may include a first column layoutformat that orients the mold objects equally such that the curvedsegment of the mold object is configured to fit into the opening segmentof another mold object (as depicted in the three-dimensionalillustration of the tray layout shown in FIGS. 13A, 13B, for example).Alternatively, in a further embodiment, column orientation including aninterlocked pair configuration for mold objects may be used such thatmold objects are oriented in opposite direction and placed at apredetermined angle. More specifically, in one aspect, the recursivelayout as shown in FIG. 13B including a segment of the tray layoutrotated by approximately 90 degrees may be used to obtain an optimizedtray layout configuration.

FIG. 10 is a flowchart illustrating the slice format generationprocedure of FIG. 7 in accordance with one embodiment of the presentinvention. Referring to FIG. 10, in one embodiment, the slice formatgeneration procedure includes determining an identifier associated withthe tray object at step 1010, and then retrieving geometry profile ofthe dental appliance such as aligners associated with the mold object inthe corresponding tray object at step 1020. Thereafter, at step 1030,one or more fabrication instructions associated with the tray object isgenerated so as to be executed by the one or more manufacturing machinesexecuting the manufacturing processes associated with the fabrication ofthe dental appliances corresponding to the fabrication data package.

For example, in one embodiment, for each tray object, the correspondingmold geometries are retrieved and a layout transformation procedure isimplemented and converted into the manufacturing machine executable fileformat such that the mold slicing procedure may be performed for eachmold object associated with the one or more tray objects for thetreatment profiles associated with the fabrication data package.

In this manner, in particular embodiments, methods and systems areprovided for automated or semi-automated manufacturing or fabricationprocess for high volume and high scale customized items such as dentalaligners. More particularly, in accordance with one or more embodiments,there is provided method and system to promptly process treatedthree-dimensional (“3D”) jaw and teeth data to generate, in an automatedmanner, 3D mold data for manufacturing. In addition, a 3D cutting pathmay be generated for automated cutting of aligners, and 3D placementdata for automated laser marking of aligners, while minimizing resinused to build a mold, minimizing time to build a tray of molds,maximizing automation by reducing manual cutting of aligner, manuallaser marking and errors. Accordingly, in particular embodiments, eachmold may be uniquely identifiable, generated substantially free ofholes, free-floating island structures, or unstable peninsulastructures, configured to efficiently use the required resin, and wherethe molds may be packed efficiently on a tray, and also, laser marks aresufficiently sharp.

As discussed above, in accordance with the various embodiments of thepresent invention, there are provided method and system for automatedfabrication process for high volume customized items where each itemincludes parameters or configurations that are unique to the particularitem. While the description above in provided in conjunction with dentalappliances, within the scope of the present invention, the automatedfabrication processing may be implemented for the manufacturing of anyhigh volume customized items including, for example, customized footweareach configured to fit a unique customer's feet dimensions, customizedapparel, customized eyewear, or any other customized consumable or othergoods where mass, high volume production generally requires customizedtooling requirements for the manufacturing machines.

A method of providing volume manufacturing of items in accordance withone embodiment of the present invention includes receiving a datapackage including a plurality of manufacturing parameters, each of theplurality of manufacturing parameters associated with a unique item,verifying the received data package, and implementing a manufacturingprocess associated with the received data package. The method in oneaspect may further include generating one or more notificationassociated the data package.

Moreover, in a further aspect, receiving the data package may includedetermining a current active processing capacity based on the receiveddata package, and retrieving additional data package for implementationof the manufacturing process substantially concurrently with thereceived data package, where the additional data package may beretrieved when the current active processing capacity is not optimizedbased on the received data package.

Moreover, verifying the received data package in a further aspect mayinclude detecting an error condition associated with one or more of theplurality of manufacturing parameters, and generating an errornotification associated with the detected error condition, wheregenerating error notification in one embodiment may include requestingan updated data package, and receiving an updated data package withoutthe detected error condition.

The detected error condition may include one or more of a missing data,or an invalid data of the data package.

Moreover, in a further aspect, implementing the manufacturing processmay include parsing the verified data package, and generating one ormore object files based on the parsed data package, each of the one ormore object files associated with a corresponding one or moremanufacturing routine, where one or more manufacturing routine may be adedicated routine associated with the manufacturing process, andfurther, where the dedicated routine may include one of athree-dimensional data generation associated with the unique item, or athree-dimensional data generation associated with a physical layout ofthe unique item.

In still another aspect, each of the one or more manufacturing routinemay be executed substantially concurrently.

The unique item in one aspect includes a dental appliance, where thedental appliance may include a dental aligner.

A method of providing high volume manufacturing process in accordancewith another embodiment of the present invention includes receiving abatch data associated with the manufacturing of a plurality of uniqueitems, and generating one or more object files associated with each ofthe plurality of unique items. In a further aspect, the batch data maybe associated with one or more dedicated processes for the manufacturingof the plurality of unique items.

Additionally, the one or more object files may include one or morethree-dimensional object data, each associated with the one or more ofthe plurality of unique items, where the one or more three-dimensionalobject data may include one or more of a geometry parameter, anidentification parameter, or a layout parameter.

A system for high volume manufacturing of customized items in accordancewith still another embodiment includes a remote terminal, and a storageunit, a controller unit operatively coupled to the storage unit, andconfigured to receive from the remote terminal, a data package includinga plurality of manufacturing parameters, each of the plurality ofmanufacturing parameters associated with a unique item, the controllerunit further configured to verify the received data package and toimplement a manufacturing process associated with the received datapackage.

The controller unit may be further configured to transmit one or morenotification associated the data package to the remote terminal.

In a further aspect, the controller unit may also be configured todetermine a current active processing capacity based on the receiveddata package, and to retrieve additional data package from the remoteterminal for implementation of the manufacturing process substantiallyconcurrently with the received data package, where the controller unitmay be configured to retrieve the additional data package from theremote terminal when the current active processing capacity is notoptimized based on the received data package.

In another aspect, the controller unit may be further configured todetect an error condition associated with one or more of the pluralityof manufacturing parameters, and to transmit an error notificationassociated with the detected error condition to the remote terminal,where the controller unit may additionally be configured to request anupdated data package from the remote terminal, and to receive an updateddata package from the remote terminal without the detected errorcondition.

In another aspect, the system may further include a fabrication terminaloperatively coupled to the controller unit, the fabrication terminalconfigured to receive the verified data package, to parse the verifieddata package, and to generate one or more object files based on theparsed data package, each of the one or more object files associatedwith a corresponding one or more manufacturing routine, where each ofthe one or more manufacturing routine may be a dedicated routineassociated with the manufacturing process.

Moreover, the dedicated routine may include one of a three-dimensionaldata generation associated with the unique item, or a three-dimensionaldata generation associated with a physical layout of the unique item.

The various processes described above including the processes performedby the central manufacturing terminal 130, the remote terminal 120, andfabrication terminals 140A, 140B (FIG. 1A) in the software applicationexecution environment in the fabrication system 100 including theprocesses and routines described in conjunction with the Figures may beembodied as computer programs developed using an object orientedlanguage that allows the modeling of complex systems with modularobjects to create abstractions that are representative of real world,physical objects and their interrelationships. The software required tocarry out the inventive process, which may be stored in the memory ordata storage unit 130A of the central manufacturing terminal 130 (and/orother equivalent storage units of the respective one or more remoteterminal 120 and fabrication terminals 140A, 140B, may be developed by aperson of ordinary skill in the art and may include one or more computerprogram products.

Various other modifications and alterations in the structure and methodof operation of this invention will be apparent to those skilled in theart without departing from the scope and spirit of the invention.Although the invention has been described in connection with specificpreferred embodiments, it should be understood that the invention asclaimed should not be unduly limited to such specific embodiments. It isintended that the following claims define the scope of the presentinvention and that structures and methods within the scope of theseclaims and their equivalents be covered thereby.

What is claimed is:
 1. A method for volume manufacturing of a pluralityof unique items, comprising the steps of: (a) initiating a predefinedfabrication processing time period; (b) upon initiating the predefinedfabrication processing time period, operating a central manufacturingprocessor in accordance with executable program instructions to retrievea fabrication data package containing manufacturing data; (c) operatingthe central manufacturing processor in accordance with the executableprogram instructions to verify the fabrication data package for accuracyand completeness of the manufacturing data contained therein; (d)operating at least one fabrication terminal to receive the verifiedfabrication data package from the central manufacturing processor and toperform at least one fabrication process in accordance with themanufacturing data contained in the fabrication data package; (e) if thepredefined fabrication time period has not expired, repeating steps (b)through (d); and (f) if the predefined fabrication time period hasexpired, operating the central manufacturing processor in accordancewith the executable program instructions to generate a status report. 2.The method of claim 1, wherein the fabrication data package is retrievedvia a data network.
 3. The method of claim 1, wherein the fabricationdata package is retrieved from a remote terminal.
 4. The method of claim1, wherein the unique items are molds for fabricating dental aligners,and wherein the manufacturing data include a three-dimensional datarepresentation of a patient's teeth for each of a plurality of dentaltreatment profiles for the patient.
 5. The method of claim 4, whereineach of the treatment profiles includes data representing each of aplurality of treatment stages, and wherein the step of operating thecentral manufacturing processor in accordance with the executableprogram instructions to verify the fabrication data package for accuracyand completeness of the manufacturing data contained therein includesverifying the accuracy and completeness of the data representing each ofthe treatment stages in each of the treatment profiles.
 6. The method ofclaim 1, further comprising the step of operating the centralmanufacturing processor in accordance with the executable programinstructions to generate a message upon completion of the verificationstep.
 7. The method of claim 6, wherein the fabrication data package isretrieved from a remote terminal, and wherein the generated message istransmitted to the remote terminal.
 8. The method of claim 3, furthercomprising the step of operating the central manufacturing processor inaccordance with the executable program instructions to output to theremote terminal periodic fabrication process status update reports. 9.The method of claim 1, further comprising the step of operating thecentral manufacturing processor in accordance with the executableprogram instructions to generate input data for the fabrication terminalto perform a fabrication process subsequent to the at least onefabrication process.
 10. The method of claim 1, further comprising thestep of operating the central manufacturing processor in accordance withthe executable program instructions to detect an error conditionassociated with the fabrication data package, and to transmit a reportincluding the error condition to a remote processor.
 11. The method ofclaim 10, wherein the remote terminal is operable to modify thefabrication data package to address the error condition and tocommunicate a modified fabrication data package to the centralmanufacturing processor.